Bioequivalence and Bioavailability Forum • Replicated design for a combination [Highly variable+Normal]

Replicated design for a combination [Highly variable+Normal] [Design Issues]

posted by jag009 – NJ, 2013-06-17 19:24 (4754 d 06:13 ago) – Posting: # 10806
Views: 5,356

Hi,

❝ Though the FDA guidnace is sugesting for a Normal crossover design for the combination. Our submission is for EMEA.

With FDA, I ran a few partial replicate studies(and have also reviewed a few while doing due diligence) for combos with 1 component being HVD (CV>30%). The mixed BE approach will enable you to run stats for RSABE and ABE anyway. With EMEA I have no clue as to whether they allow you to use partial replicate (I don't see why as long as you can provide evidence that 1 component is HVD).

See example from FDA, link

Thanks
John

Complete thread:

Replicated design for a combination [Highly variable+Normal] Naveen Kumar 2013-06-17 14:37
- Replicated design for a combination [Highly variable+Normal]jag009 2013-06-17 17:24
  - Replicated design for a combination [Highly variable+Normal] Naveen Kumar 2013-06-18 14:53
    - Replicated design for a combination [Highly variable+Normal] Dr_Dan 2013-06-19 12:04
      - Replicated design for a combination [Highly variable+Normal] Naveen Kumar 2013-06-21 05:19